Friday, January 12, 2018 12:54:01 PM
Dear Mr Soulliere,
Thank you for your email regarding Akers Biosciences and for your continued support as a shareholder. I am happy to answer your question below on the company’s behalf.
The company is extremely excited by the potential for rapid chlamydia assay which is a single-use device based on Akers Bio’s proprietary PIFA technology, using whole blood, and getting results within 5 minutes vs. 24-72 hours for outsourced lab results. Given it tests for the most prevalent sexually transmitted disease, the market size potential is considerable.
The target markets include but are not limited to: Planned Parenthood, ambulatory care, clinics, urgent care, federally qualified health clinics, US Government and college campus clinics. The strategic focus is on turnaround time: achieving diagnosis and, if necessary, prescribing treatment prior to patient leaving facility (unlike existing formats).
The test was submitted for FDA market clearance in May 2017. The company continues to work proactively with the FDA and is confident in its data package and submission but – as with any FDA product clearance – the company has no visibility over a market clearance date. The company continues to target a 2018 launch.
I hope this information is useful and please do not hesitate to contact us should you have further questions in the future.
Yours sincerely,
Emma Lord
For Akers Bio
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